Vericiguat in Italian clinical practice: insights from the OpTIMa-HF registry and comparison with the VICTORIA trial
F Marzano, S Paolillo, P Gargiulo, E Carluccio, A Cittadini, C Indolfi, M Metra, I Porto, M Senni, A Curcio, A Polimeni, S Carugo, D Bruzzese, P Ameri, P Perrone-FilardiAbstract
Background/Introduction
Vericiguat is recommended for the treatment of heart failure (HF) with reduced ejection fraction (HFrEF) based on the results of the VICTORIA trial, which enrolled 5,050 symptomatic patients with chronic HF and left ventricular ejection fraction <45%, randomised to vericiguat or placebo in addition to standard therapy. Vericiguat significantly reduced the composite endpoint of cardiovascular death or first HF hospitalisation by 10%. Despite these favourable results, real-world data on the use of vericiguat remain limited.
Purpose
The aim of this analysis was to describe the baseline characteristics of patients with chronic HF treated with vericiguat in Italian clinical practice and to compare them with those of patients enrolled in the VICTORIA trial.
Methods
We retrospectively collected data from patients with a new prescription of vericiguat across 21 centres participating in the OpTIMa-HF registry. Baseline characteristics at the time of prescription were compared with those of patients included in the VICTORIA trial.
Results
A total of 572 patients were included (mean age 70.5 ± 11.1 years; 27.4% women). Comorbidities were highly prevalent: hypertension in 67.8%, diabetes in 41.1% and chronic obstructive pulmonary disease in 24.3%. Most patients were in NYHA functional class II (43.5%) or III (42.5%), and the predominant aetiology was ischaemic (57.5%). Compared with VICTORIA patients, those in the OpTIMa-HF registry were older (70.1 ± 11.7 vs 67.5 ± 12.2 years; p<0.001), exhibited lower systolic blood pressure (115.2 ± 17.2 vs 121.2 ± 15.7 mmHg; p<0.001) and more impaired renal function (median estimated glomerular filtration rate 48 vs 58.4 mL/min/1.73 m2; p<0.001), while NT-proBNP levels were similar. Regarding HF therapy, patients in VICTORIA trial were more frequently treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (73.3% vs 14.5%; p<0.001), whereas angiotensin receptor–neprilysin inhibitors use predominated in the OpTIMa-HF registry (65.6% vs 14.3%; p<0.001), together with a greater use of mineralocorticoid receptor antagonists (79.4% vs 69.3%; p<0.001). Beta-blocker use was high in both cohort, with a similar proportion of patients receiving triple therapy. In addition, 84.3% of OpTIMa-HF patients were treated with sodium–glucose co-transporter-2 inhibitors and 82.9% with loop diuretics, with a 56.6% of patients treated with the 4 pillars recommended by current guidelines.
Conclusions
In Italian clinical practice, vericiguat is prescribed to older and more functionally impaired patients than those enrolled in the VICTORIA trial, supporting good tolerability and clinician confidence in fragile populations. These patients show high adherence to guideline-recommended therapy, with over half receiving all four foundational treatment pillars.